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What is depression?
Many of us say "I'm feeling depressed" when we feel sad or miserable. But usually, these feelings pass after a while. But clinical depression is when these feelings are disabling and interfer with your life. Clinical depression can stop people from leading a normal life, it makes everything harder to do and everything may seem less worthwhile. At its most severe depression can be life-threatening, because it can make people suicidal or simply give up the wil

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

l to live.

How do I know if I am depressed?
You may be ‘clinically’ depressed if you have most of the following symptoms:

depressed mood most of the day, nearly every day, that may be noticed by others.
Loss of interest or pleasure in all, or almost all, activities most of the day, nearly every day
significant weight loss when not dieting or weight gain or decrease or increase in appetite nearly every day.
insomnia or hypersomni

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

nearly every day

psychomotor agitation or retardation nearly every day

loss of energy nearly every day

feelings of worthlessness or excessive or inappropriate guilt nearly every day

diminished ability to think or concentrate, or indecisiveness, nearly every day

recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

What types of depression are there?

General Depression
People who suffer from general depression still have most of the major signs and symptoms of depression as discussed above. Depression can very from mild to moderate to sever (which is sometimes called major depression).
Seasonal affective disorder
This happens when someone becomes depressed only during the autumn and winter, and it is caused by not getting eno

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

gh daylight.

Postnatal depression
Also known as "the baby blues". This is a depression that occurs after the birth of their baby and can appear any time between two weeks and two years after the birth.

Manic depression
Also known as Bipolar Disorder. Some people have mood swings, with periods of depression that then change into periods of mania. Mania is a state of high excitement, and peope who are manic may plan or believe lofty schem

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s and ideas.

What causes depression?
There's no one cause of depression; it varies from person to person and can happen for a combination of factors. Although depression there has been not enough evidence to believe that is is something inherited in the genes, some of us are more prone to depression than others. Some factors that could cause depression include:

the way we're made
our experiences
family background.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

i>traumatic life events

poor coping strategies

after a loss of some sort (loved one, job, house etc)

life changes

inability to adapt

physical illness

poor diet and lifestyle

chemical imbalances

What can you do to help yourself?
Remember that depression can feed on itself. In other words, you get depressed and then you get more depressed about being depressed. An important thing to remembe

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

is that there are no instant solutions to problems in life. Solving problems involves time, energy and work. Here are some things you can do to try and break the hold of low moods:

Make an effort to be more aware of how you talk and think to yourself. Listen to yourself in your head.
Every time something negative crops up, quickly scrap that thought and think of something kinder, more encouraging things to say to yourself. For instance, when you have to do something, if you

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

always say to yourself, ‘You’re sure to fail. You always make a mess of everything you do’ try to ‘delete’ those thoughts and replace it with something like: ‘You’re going to do the best you possibly can.

Look for things to do that occupy your mind.

Although you may not feel like it, it’s very therapeutic to take part in physical activities, for 20 minutes a day. This can stimulate chemicals in the brain called endorphins, which can help you to feel better.

Try doing th

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ings that will improve the way you feel about yourself. Allow yourself treats. Pay attention to your personal appearance. Set yourself daily or weekly goals that you can achieve. Look after yourself by eating healthily.

Try some alternative therapies such as acupuncture, massage, homeopathy and herbal medicine. St John's Wort is one of the herbal remedies that have become very popular, and may help to lift your mood. But if you are already taking other medication, it may not be safe to com

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ine them. Consult your pharmacist or GP for more information.

It can be a great relief to meet and share experiences with other people who are going through the same thing you are. It can break down isolation and can show you how other people have coped and that is how SpeakOut and support groups can help.

Remember to try and value and accept yourself. If you’ve spent most of your life believing that you’re unacceptable and of little value, it’s hard to change yourself for the be

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ter, because all your ideas and ways of behaving are based on that assumption.

Question the assumptions on which you base your ideas. Is it really true that everybody in the whole world hates you, or that everything you’ve ever done has turned out badly? Is it really true that you have nothing worthwhile in your life?

Try to remember how you came to think and feel this way.

Writing these things down puts what you’re thinking and feeling outside of yourself, and you can

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

see it more clearly. Books can be helpful. Try reading, not just self-help books, but well-written novels, poetry and biography.

Talk about these things to other people and find out how they see things. Talk to friends, call at a local drop-in centre, join a self-help group. Talking to a therapist or counsellor can be very helpful.

What can you do if you think you need more help?
If you find your depression is effecting your daily functioning and

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

as been present for a length of time now, it may be worth seeking the advice of your local doctor. Also if you have been going through a lengthy period of consecutive suicidal thoughts then it may be a good idea to seek out some reassuring aid from your local doctor if you haven’t already. 4 out of 10 appointments at G.P. surgery’s are on the concerns of a persons mental and emotional well-being, so there’s no need to feel like your the only one. Here are some of the things the doctor can offer:

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

Antidepressants - These are drugs which work on chemical messengers in the brain to lift your mood. It often takes between 2-4 weeks before the drugs take effect. The usual recommendation is that you stay on them for six months.

Psychological treatments - This is things like therapy and counselling. Many people find it helpful to talk about their difficulties to someone who is trained in listening skills. The therapist or counsellor can also help you

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

to put your problems in perspective and to develop new coping and problem solving strategies.

Befriending schemes - Your doctor may put you in touch with a local befriending scheme this will lead to trained volunteers visiting you regularly to give you practical advice, support and a sympathetic ear.

Support groups - This is when you meet up and talk with other people who are feeling the same way as you and share your experiences. This can be hel

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ful to discover what works for other people and how other people cope.

What if the depression gets worse?
If you are severely depressed then you may need more intensive aid. Your doctor may refer you to a psychologist, psychiatrist or mental health nurse. The sort of services that you may be on offer for you include:

Community Mental Health Teams (CMHTs) - These are often the most easily accessible service for people with mental

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ealth problems. They can provide support for people living in their own homes. The CMHTs include a psychiatrist, community psychiatric nurses (CPNs), social workers and support workers etc. These professionals will visit you at your own home or refer you to Day Hospitals or Day centres where you spend the day but return home afterwards.

Crisis resolution services - These are teams of doctors and nurses who provide support during crisis situations, and will help you to stay

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

at home if you're in crisis, rather than go into hospital.

Electroconvulsive therapy (ECT) - This is a controversial treatment, that is only offered when people who are severely depressed and have not responded to any other treatment. It involves passing an electric current through the brain, while you are under general anaesthetic. I’ve witnessed this being done several times and in my opinion it sounds worse than it really is.

Hospital admission -
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ng> If you are severely depressed and are a significant risk to yourself or others you may need the shelter and security of a ward hospital. It also gives a chance for the health professionals to monitor the effects of different treatments. Hospital can provide a safe, supportive environment if you are in a state of distress. Generally however doctors want to avoid placing people in hospital, but some patients are compulsorily detained if they are a dangerous risk to others or themselves.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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